Arthrosamid Injection for OA Knee

NCT05086068 | Unknown

• 1 other identifier: RL1 840
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Prior to surgical intervention, the conservative treatment of knee osteoarthritis involves analgesia and intra-articular injections and currently only steroid injections are available as part of NHS treatment. They have short-term benefit only (\<6months) and potentially have detrimental effects on residual cartilage. Arthrosamid is a hydrogel consisting of 97.5% sterile water and 2.5% cross-linked polyacrylamide. It's been shown to be safe and effective, with benefits lasting beyond 2 years in the majority. However, currently it is unclear via what biological pathways it reduces joint inflammation and pain. This study will investigate the effects of Arthrosamid clinically and biologically.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score between baseline (pre-injection) and 6 months and 12 months post-injection.

  The WOMAC score includes 3 subscales related to pain, stiffness and function; the higher is the WOMAC score, the worse is the joint function.

  6 months and 12 months post injection

Secondary Outcomes (3)

• Blood and synovial fluid biochemical and biomarker levels pre- and post-injection

  Pre-injection and at 3 months

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Pre-injection, 3, 6 and 12 months post-injection

• Analgesia requirement 1 week prior to Patient Reported Outcome Measurement (PROM) collection

  Pre-injection, 3, 6 and 12 months post-injection

Study Arms (1)

Arthrosamid Inj

OTHER

Single arm study - no comparator

Device: Arthrosamid

Interventions

Arthrosamid DEVICE

Intra-articular hydrogel injection comprising of water and cross-linked polyacrylamide.

Arthrosamid Inj

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary OA according to the American College of Rheumatology criteria1.
• Self-reported pain, aching, or stiffness of the index knee on most days of the past month, and a knee pain score of greater than 40 out of 100 on a visual analogue scale (VAS).
• Radiological OA greater than Kellgren-Lawrence (K-L) grading scale 2
• Patients aged over 18 years
• Patient willing to undergo synovial sampling at 3 months post injection.

You may not qualify if:

• Previous trauma with significant alteration in bone architecture
• Symptoms of spinal disease
• Prior injection in the last 12 months
• Joint re-placement operation on the other knee
• Cognitive disorders
• Inflammatory arthritis (i.e., rheumatoid arthritis, spondylarthritis and gout)
• Fibromyalgia
• Auto-immune disease (i.e., connective tissue disorders)
• Previous history of septic arthritis.
• Unwilling or unable to give informed consent

Sponsors & Collaborators

• Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust: lead

Study Sites (1)

The Robert Jones and Agnes Hunt Orthopaedic Hospital

Oswestry, Shropshire, SY10 7AG, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Single site, single group of patients identified as requiring treatment for early Osteoarthritis of the knee.

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 20, 2021
• Study Start: November 16, 2022
• Primary Completion: December 19, 2023
• Study Completion: December 1, 2024
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)